Research & Certifications

Built on science.
Backed by clinical research.

The ReliveX Adaptive Correction System is built on Neuromuscular Electrical Stimulation (NMES) — a technology that has been studied in peer-reviewed journals for the activation of deep spinal stabilizing muscles and the relief of chronic lower back pain.

FDA-Cleared (K231648)
CE-Certified
RoHS-Compliant
150,000+ Customers Worldwide
The Science

Five clinical studies on NMES for low back pain.

The studies referenced below were conducted independently and are publicly available through the U.S. National Institutes of Health. They were not funded by ReliveX or conducted using a ReliveX device — they reference the underlying technology our device uses.

Disclaimer: The research below is referenced for educational purposes. ReliveX did not fund or conduct any of the studies cited. Full studies can be viewed on the National Institutes of Health website using the citation links provided.
STUDY 01

NMES training results in enhanced activation of spinal stabilizing muscles and improvements in pain ratings.

"Analysis of results revealed clinically and statistically significant improvements in indicators of both muscle groups' performance, as evidenced by ultrasound evaluation of activation during voluntary activity. These improvements were associated with significant improvements in self-reported pain levels, suggesting that NMES has an important role to play in Chronic Lower Back Pain rehabilitation."

Coghlan, S., Crowe, L., McCarthypersson, U., Minogue, C., & Caulfield, B. (2011). https://www.ncbi.nlm.nih.gov/pubmed/22256103
STUDY 02

The effects of NMES on the activation of deep lumbar stabilizing muscles in patients with lumbar degenerative kyphosis.

"In conclusion, lumbar stabilizing muscles of patients with Lumbar Degenerative Kyphosis were significantly activated by NMES. Protocol A+B maximally stimulated all the studied deep spinal stabilizing muscles (LM, TrA and OI) as evidenced by RUSI. The protocol may aid the development of practical NMES systems for LDK patients who suffer from postural deformity and Lower Back Pain."

Kim, S. Y., Kim, J. H., Jung, G. S., Baek, S. O., Jones, R., & Ahn, S. H. (2016). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4792980/
STUDY 03

Clinical effects of electrical stimulation therapy on lumbar disc herniation-induced sciatica.

"In the treatment of lumbar disc herniation-induced sciatica, electrical stimulation therapy can effectively reduce the pain degree, relieve the clinical symptoms and signs, improve the peripheral ROS level and prevent the oxidative damage of myocardial tissues and other complications, so it is worthy of clinical application and promotion."

Wang, L., Fan, W., Yu, C., Lang, M., & Sun, G. (2018). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6146184/
STUDY 04

Trunk muscle training augmented with NMES improves function in older adults with chronic low back pain.

"Clinically important reductions in pain of greater than 2 points on a numeric pain rating scale during the course of the trial. Only the TMT+NMES group had clinically important improvements in both performance-based and self-reported measures of function. In terms of the participants' global rating of functional improvement at 6-months, the TMT+NMES group improved by 73.9%."

Hicks, G. E., Sions, J. M., Velasco, T. O., & Manal, T. J. (2016). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4935645/
STUDY 05

Electrical muscle stimulation as an adjunct to exercise therapy in nonacute low back pain: a randomized trial.

"At the 2-month follow-up interval, subjects in the treatment group had statistically significantly improved lumbar spine function compared with the control subjects. This effect continued during the last 4 months of the study after electrical stimulation had been discontinued. This suggests that electrical muscle stimulation can be an effective adjunctive treatment modality for nonacute low back pain."

Glaser, J. A., Baltz, M. A., Nietert, P. J., & Bensen, C. V. (2003). https://pubmed.ncbi.nlm.nih.gov/14622808/
The Mechanism

Why the multifidus matters.

The multifidus is a deep stabilizing muscle that runs along the spine. After spinal injury, surgery, or long periods of pain, research has shown this muscle can become inhibited — the brain effectively shuts it down, leaving the spine without its natural support system.

Surface-level approaches like conventional TENS units can only reach 5–8mm beneath the skin. The Adaptive Correction System uses NMES at a depth that targets the deep stabilizing muscle layer — the layer most studies on chronic lower back pain rehabilitation focus on.

30–50mm
NMES Depth
5–8mm
Conventional TENS
SKIN · 0–5mm SURFACE MUSCLES · 5–8mm ← TENS reaches INTERMEDIATE LAYER MULTIFIDUS · 30–50mm Deep stabilizing muscle ← NMES reaches SPINE / VERTEBRAE Cross-section: depth of stimulation
Regulatory & Quality

FDA-cleared. CE-certified. Built to medical-grade standards.

In a market filled with cheap counterfeit devices, ReliveX is committed to safety and quality. Our Adaptive Correction System has been evaluated under the strictest international standards.

The device is FDA-cleared under 510(k) number K231648, regulated as a Class II medical device under 21 CFR 882.5890 and 21 CFR 890.5850, and is cleared for over-the-counter use.

FDA 510(k) NumberK231648
Device ClassClass II
Regulation21 CFR 882.5890
Clearance DateMarch 1, 2024
Type of UseOver-The-Counter

FDA-Cleared

Reviewed by the U.S. Food and Drug Administration under 510(k) clearance K231648.

CE Certification

Meets European health and safety standards for medical devices.

RoHS Compliant

Free of hazardous substances like lead and mercury — safe for you and the environment.

Benelux Trademark

Officially registered as a brand in the Benelux — a trusted name in the region.

Got Questions?

Frequently asked.

Everything we get asked about the science, the certifications, and how the Adaptive Correction System works.

Is the ReliveX Adaptive Correction System the same as a TENS unit?

No. While both use electrical stimulation, they target different layers of tissue. Conventional TENS units operate at a depth of roughly 5–8mm and are designed to interrupt surface-level pain signals. The Adaptive Correction System uses NMES (Neuromuscular Electrical Stimulation), which reaches the deeper stabilizing muscle layer at 30–50mm — the layer that the clinical studies above focus on.

What does FDA-cleared mean exactly?

FDA clearance under the 510(k) pathway means the device has been reviewed by the U.S. Food and Drug Administration and determined to be substantially equivalent to other legally marketed medical devices in terms of safety and effectiveness. Our 510(k) number is K231648, and the device is regulated as a Class II medical device cleared for over-the-counter use.

It's worth noting that "FDA-cleared" and "FDA-approved" are not the same thing. Approval is a separate, stricter regulatory pathway reserved for high-risk Class III devices. Our device is cleared, which is the appropriate regulatory status for a Class II device of this type.

Were the clinical studies on this page conducted using a ReliveX device?

No. The studies referenced on this page were conducted independently by university researchers and published in peer-reviewed journals, accessible through the U.S. National Institutes of Health. They were not funded by ReliveX and were not conducted using a ReliveX device. They reference the underlying NMES technology that our device uses.

We share them so you can independently evaluate the science behind the technology.

Who should not use this device?

The device is not suitable for anyone with a pacemaker, an implanted cardioverter-defibrillator (ICD), or any other active implanted electrical device, including active spinal cord stimulators. It is also not recommended during pregnancy or for individuals with epilepsy or active cancer.

Passive implants such as titanium hardware from spinal fusion surgery are generally considered safe with NMES, but we always recommend checking with your healthcare provider before starting any new therapy.

How long does it take to see results?

Results vary from person to person. Some users report noticeable changes within the first few weeks, while others see more gradual improvement over a longer period. The studies referenced on this page generally measured outcomes over 8 weeks to 6 months.

Because every body is different, we offer a 90-day risk-free trial period — so you can evaluate the device on your own timeline.

Where can I read the full studies?

Each study above includes a direct citation link to the U.S. National Institutes of Health (NIH) database, where the full peer-reviewed paper can be read free of charge. We encourage anyone interested to review the original sources directly.

Is the device safe to use at home without a doctor?

Yes. The Adaptive Correction System is FDA-cleared for over-the-counter use, meaning it has been determined to be safe for at-home use without a prescription. That said, if you have any pre-existing medical condition or implanted device, we always recommend consulting your healthcare provider before starting.

Have a question we didn't answer?

Our team is here to help. Whether it's about the science, the certifications, or whether the device is right for your specific condition — we'll give you a straight answer.

Contact Our Team Shop ReliveX